MHRA-100046-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • cenobamate
Invented Name
  • ONTORZY
  • Xcopri
PIP Number MHRA-100046-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet, Tablet, Oral suspension, Solution for injection
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of epilepsy
Route(s) of administration
  • Oral use
  • Parenteral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
27/09/2021
Compliance Check Procedure Number
Compliance procedure number
MHRA-100046-PIP01-21-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):cenobamate.pdf
Published Date 03/11/2021